The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Device Description

The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the illumination and imaging optics. The Camera Enabled Probes are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor is 220mm X 135mm X 39mm. The entire unit weight is less than 300 grams.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Camera Enabled Probe." The regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and testing against those criteria in a way that would be typical for an AI/ML device.

Therefore, the requested information elements related to AI/ML device performance (like specific performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not present in the provided document. The document describes functional and safety testing to ensure the device meets predefined technical standards, which are different from a clinical performance study with statistical results against acceptance criteria for a diagnostic aid.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists industry standards that the device underwent testing against for functional and safety aspects. These are not performance metrics in the sense of accuracy, sensitivity, or specificity for a diagnostic output, but rather specifications for the device's physical and operational attributes.

Acceptance Criteria (Industry Standards Applied)	Reported Device Performance (Implied by Conclusion)
ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	Device design meets functional and performance requirements (biocompatibility assessed).
IEC-60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)	Device design meets functional and performance requirements (electrical safety and essential performance assessed).
EN-60601-1-2 (Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance. Collateral Standard. Electromagnetic Compatibility. Requirements and Tests)	Device design meets functional and performance requirements (EMC assessed).
ISO-11135-1 (Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices)	Device design meets functional and performance requirements (sterilization process validated).
ISO-9626 (Stainless Steel Needle Tubing for the Manufacture of Medical Devices)	Device design meets functional and performance requirements (material specifications met).
ISO-7864 (Sterile Hypodermic Needles for Single Use)	Device design meets functional and performance requirements (needle specifications met).

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any specific clinical performance test. The testing mentioned refers to "representative samples" for functional and safety testing.
Data Provenance: Not applicable as no clinical performance study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical performance test with expert-established ground truth is described.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance study was done. This is not an AI device.

7. The type of ground truth used:

Not applicable, as no clinical ground truth for diagnostic accuracy is presented. The "ground truth" for the functional and safety tests would be the specifications outlined in the respective standards.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device and no training set is mentioned.

9. How the ground truth for the training set was established:

Not applicable.

Overall Study Description:

The provided document describes a technical performance and safety assessment rather than a clinical performance study. The study presented focuses on ensuring the device (Camera Enabled Probe) meets established industry standards for:

Biocompatibility (ISO 10993-1)
Electrical safety and essential performance (IEC-60601-1)
Electromagnetic compatibility (EN-60601-1-2)
Sterilization validation (ISO-11135-1)
Material specifications (ISO-9626, ISO-7864)

The conclusion states that Trice Medical, Inc. considers the Camera Enabled Probe to be equivalent to the predicate device (K093717 - C-MOR Visualization System) based on:

Similarities in indications for use.
Principles of operation.
Technology.
Materials.

This type of submission (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on non-clinical performance data and comparison to the predicate's technical specifications and safety profile, rather than a de novo clinical performance study against specific diagnostic acceptance criteria.

Summary

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JUL 2 9 2014

2.0 510(k) Summary

Table 1: 510(k) Summary
Submitter:	Trice Medical, Inc.1000 Continental Drive, Suite 240King of Prussia, PA 19406
Contact Person:	Tiffini DiageConsulting Director Regulatory AffairsPhone: 707.799.6732E-mail: tdiage@raechelon.com
Date Prepared: ·	4/29/14
Trade Name:	Camera Enabled Probe
Common Name:	Arthroscope
Classification:	Class II
Product Code:	HRX, 888.1100
Predicate Device(s):	The subject device is equivalent to the following devices:• K093717 - C-MOR Visualization System
Device Description:	The Camera Enabled Probe is a battery operated, portable,visualization device that uses a probe with integrated cameraand separate LCD monitor attached via cable. The sterile,single-use probe includes the camera and image capturefeatures with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to providepower to the probe. The probe scope extends from the handleas a rigid shaft with retractable needle and flushing port forcleaning the field of view. The distal tip of the probe containsthe illumination and imaging optics.The Camera Enabled Probes are identical in design and functionand available in three lengths: 50mm, 95mm, and 160mm. Themonitor is 220mm X 135mm X 39mm. The entire unit weight isless than 300 grams.
Indication for Use:	The Camera Enabled Probe is indicated for use in diagnostic andoperative arthroscopic and endoscopic procedures to provideillumination and visualization of an interior cavity of the bodythrough either a natural or surgical opening.

Trice Medical, Inc.

Premarket Notification for the Camera Enabled Probe

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Functional andSafety Testing:	To verify that device design meets its functional andperformance requirements, representative samples of thedevice underwent biocompatibility, software, electrical, andmechanical testing in accordance with the following industrystandards.
	ISO 10993-1:2009 Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process
	IEC-60601-1 > Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and Essential Performance
	EN-60601-1-2 > Medical Electrical Equipment. GeneralRequirements for Basic Safety and Essential Performance.Collateral Standard. Electromagnetic Compatibility.Requirements and Tests
	ISO-11135-1 > Sterilization of Health Care Products. EthyleneOxide. Requirements for Development, Validation and RoutineControl of a Sterilization Process for Medical Devices
	ISO-9626 > Stainless Steel Needle Tubing for the Manufacture ofMedical Devices
	ISO-7864 > Sterile Hypodermic Needles for Single Use
Conclusion:	Trice considers the Camera Enabled Probe device to beequivalent to the predicate device listed above. This conclusionis based upon the devices' similarities in indications for use,principles of operation, technology, and materials.

Trice Medical, Inc.

Page 2 of 2

Premarket Notification for the Camera Enabled Probe

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2014

Trice Medical Incorporated Ms. Tiffini Diage Consulting Director Regulatory Affairs 1000 Continental Drive, Suite 240 King of Prussia, Pennsylvania 19406

Re: K141119

Trade/Device Name: Camera Enabled Probe Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class; Class II Product Code: HRX Dated: July 17, 2014 Received: July 18, 2014

Dear Ms. Diage:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Tiffini Diage

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDeviccs/ResourcesforYou/Industry/default.htm.

Sincerely yours.

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

KI4119

Device Name Camera Enabled Probe

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

.... FOR FDA USE ONLY .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

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Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.